Clinician acceptance and storage
The GE family support article describes reviewing, accepting and storing the calculated EF result; family details are not asserted as exact K243862 configuration.
product family · checked 2026-09-07FDA-cleared profile
LVivo Software Application
DiA Imaging Analysis Ltd.
Authorized purpose: Automated echocardiographic LV and RV function, wall-motion and strain, bladder-volume and image-quality measurements for clinician review.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Automated echocardiographic LV and RV function, wall-motion and strain, bladder-volume and image-quality measurements for clinician review.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Automated echocardiographic LV and RV function, wall-motion and strain, bladder-volume and image-quality measurements for clinician review.
- Which images or clinical context are in scope? Modality: Ultrasound Anatomy or clinical context: Heart/Cardiovascular Input: Adult echocardiography DICOM clips and standard apical or parasternal views, including 4-chamber, 2-chamber, 3-chamber, short-axis and long-axis views as applicable to the module.
- Who uses it? Intended users: Healthcare professionals interpreting adult echocardiography examinations.
- What does the software produce? Output: LV and RV function measures, modified wall-motion score index, strain and image-quality outputs, including measurements derived from automatically selected or analyzed echo views.
- What is its most important limitation? Key limitation: The exact clinical validation used GE and Philips systems at three centers and included 170 examinations; the family GE support article describes additional probe, view-quality and adult-use conditions that are not promoted as exact K243862 labeling.
Clinical takeaway
Clinical role: Automated echocardiographic LV and RV function, wall-motion and strain, bladder-volume and image-quality measurements for clinician review.
Evidence takeaway
Evidence from the reviewed source record: The exact FDA clinical validation included 170 examinations; among 139 automatically processed examinations, modified WMSI sensitivity was 82%, specificity 79%, accuracy 82%, and Pearson correlation with the reference was 0.89.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- Automated echocardiographic LV and RV function, wall-motion and strain, bladder-volume and image-quality measurements for clinician review.
- Intended users
- Healthcare professionals interpreting adult echocardiography examinations.
- Care setting and population
- Adult echocardiography services using DICOM echo examinations.
- Workflow role
- Automated measurement and wall-motion review aid that requires professional interpretation of the echocardiogram and its outputs.
- Required input
- Adult echocardiography DICOM clips and standard apical or parasternal views, including 4-chamber, 2-chamber, 3-chamber, short-axis and long-axis views as applicable to the module.
- Output and human action
- LV and RV function measures, modified wall-motion score index, strain and image-quality outputs, including measurements derived from automatically selected or analyzed echo views.
- Limitations
- The exact clinical validation used GE and Philips systems at three centers and included 170 examinations; the family GE support article describes additional probe, view-quality and adult-use conditions that are not promoted as exact K243862 labeling.
Regulatory identity
FDA record and catalog context
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The current LVivo family support article describes clinician acceptance and storage of measurements; a Konica Minolta and DiA release describes a family PACS deployment on Exa Cardio PACS, but neither establishes the exact K243862 interface configuration.
- Deployment and data flow
- Research pending
Attach an exact-product deployment and data-flow source.
- Security and privacy
- Vendor documentation pending
No current exact-release security attestation was established.
- Training and support
- Vendor documentation pending
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Monitoring and change control
- Vendor documentation pending
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
PACS deployment pattern
A Konica Minolta and DiA release describes LVivo family analysis and reporting on Exa Cardio PACS; the release is historical and does not establish current K243862 availability.
product family · checked 2026-09-07DICOM echo workflow
The exact FDA labeling describes processing adult echocardiography DICOM studies and producing clinician-reviewable measurements.
exact submission · checked 2026-09-06Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
- Evidence summary
- The exact FDA clinical validation included 170 examinations; among 139 automatically processed examinations, modified WMSI sensitivity was 82%, specificity 79%, accuracy 82%, and Pearson correlation with the reference was 0.89.
- Reported sensitivity
- 82%
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 82%
Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
Modified WMSI sensitivity
82 percent
- EndpointWall-motion score index classification
- Population139 automatically processed examinations from a 170-examination validation set using GE and Philips systems at 3 centers
- Tested versionLVivo Software Application release reviewed in K243862
Modified WMSI specificity
79 percent
- EndpointWall-motion score index classification
- Population139 automatically processed examinations from a 170-examination validation set using GE and Philips systems at 3 centers
- Tested versionLVivo Software Application release reviewed in K243862
Modified WMSI Pearson correlation
0.89 correlation
- EndpointAutomated versus reference wall-motion score index
- Population139 automatically processed examinations from a 170-examination validation set using GE and Philips systems at 3 centers
- Tested versionLVivo Software Application release reviewed in K243862
LVivo Software Application modified WMSI validation
- DesignRetrospective multi-center clinical validation against expert reference
- PopulationAdult echocardiography examinations from GE and Philips systems at three centers
- Scopeexact submission
- Tested versionLVivo Software Application release reviewed in K243862
- Samplen=170
- Sites3
- IndependenceSponsor or vendor study
K243862 FDA 510(k) summary
The FDA summary reports 166 examinations processed and 139 automatically processed for the main analysis.
Costs and setup
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Not established in reviewed sources
No numeric price was published in the reviewed sources.
- Reimbursement and coding
- Research pending
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
- Postmarket safety review
- Not established in reviewed sources
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
- Verify deployment and data flow: Attach an exact-product deployment and data-flow source.
- Verify security and privacy controls: No current exact-release security attestation was established.
- Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Verify pricing and total cost: No numeric price was published in the reviewed sources.
- Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
- Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
- Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-07Last searched
23Fields reviewed
12Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The stored candidate metadata contained empty PubMed and clinical-trial ID arrays; metadata was screened, not full-text or registry-reviewed. The stored recall candidate record was empty and no event was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, vendor product page, vendor manual, vendor press release, peer reviewed publication, clinical trial registry, recall database, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history
Source ledger
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K243862 FDA decision source
Scope: regulatoryIdentity, purpose, modality, anatomy
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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LVivo Software Application model card (K243862)
Scope: intendedUsers, output, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
FDA 510(k) decision record and summary reviewed for LVivo Software Application, K243862
Scope: identity, intended_use, performance, limitations, implementation
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LVivo EF App support article
Scope: product_family, clinical_workflow, outputs, limitations
-
Konica Minolta and DiA expand AI-based echocardiography analysis and reporting on Exa Cardio PACS
Scope: product_family, PACS_integration, workflow
Research history
-
K243862 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
human reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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